The use of study registration and protocols in plastic surgery research: A systematic review

Background: In 2013, the Declaration of Helsinki changed to mandate that all research studies involving human subjects, rather than just clinical trials alone, must have a protocol registered in a publicly accessible database prior to the enrolment of the first patient. The objective of this work was to assess the number of research studies involving human participants published in leading journals of plastic surgery that had either published a protocol or registered a protocol with a publicly accessible database.

Materials and methods: This systematic review examined all research articles involving human participants published in Plastic and Reconstructive Surgery, The Journal of Plastic Reconstructive and Aesthetic Surgery and The Annals of Plastic Surgery from 1st April 2014-31st March 2015. The primary outcome measure was whether each study had either published or registered a protocol with any mainstream registry database. ClinicalTrials.gov, the International Standard Randomized Control Trial Number (ISRCTN) registry, the WHO (World Health Organisation) International Clinical Trials Registry Platform, The Cochrane Collaboration, the Research Registry, PROSPERO and PubMed were all reviewed.

Results: Of 595 included articles, the most common study designs were case series (n = 185, 31.1%). There were 24 randomized controlled trials (RCTs, 4.0%). A total of 24 studies had a protocol registered (4.0%). The most common database to register a protocol was with ClinicalTrials.gov (n = 17). The study design that most commonly had a registered protocol was the RCT (n = 8 of 24, 33.3% of RCTs). Three studies published a protocol in a journal (0.6%).

Conclusion: Publication or registration of protocols for recent studies involving human participants in major plastic surgery journals is low. There is considerable scope to improve this and guidance is provided.